Drugs
FDA has published a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products, to provide sponsors, researchers, and other interested stakeholders with considerations when proposing to use electronic health records (EHRs) or medical claims data in
Drugs
FDA says its review of a Web site and social media pages maintained by Supplement Science Corp., doing business as Condemned Labz, Brooklyn, NY, found significant violations of the Federal Food, Drug, and Cosmetic Act, including selling misbranded unapproved new drugs. A 9/22 Warning Letter lists claims the company
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s ongoing efforts to advance investigational drug safety reporting and provide guidance about sponsor responsibilities for safety assessments. In a 9/24 comment letter on an agency draft guidance, Sponsor Responsibilities — Safety Reporting Requirements for IND and Bioavailability/Bioequivalence
Drugs
FDA has granted priority review for ViiV Healthcare’s NDA for investigational, injectable cabotegravir long-acting for pre-exposure prophylaxis for preventing HIV. The company says the drug already received breakthrough therapy designation from FDA. The agency set a PDUFA target action date of 1/24/22. ViiV says the
Drugs
FDA has accepted for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed on or after chemotherapy. The user fee review action target date is 1/30/2022. The submission is based on data
Drugs
Pfizer has submitted a clinical trial protocol amendment to a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne Muscular Dystrophy patients after three severe adverse events were reported. Based on these adverse events, individuals with mutations (exon deletion, exon duplication, insertion, or point mutation) affecting exons 9 through
Drugs
Eli Lilly has recalled one lot of its Glucagon Emergency Kit for Low Blood Sugar (glucagon for injection, 1 mg per vial; diluent for glucagon, 1 mL syringe) after receiving a product complaint reporting that a vial of glucagon was in liquid form instead of the powder form. A company
Drugs
FDA has accepted for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) and Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatments for adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma. The agency has set
Drugs
FDA has removed a clinical hold against a GeneTx Biotherapeutics and Ultragenyx Pharmaceutical clinical trial of GTX-102, an investigational treatment for Angelman syndrome. The companies are now permitted to begin dosing naive patients in a Phase 1/2 study in the U.S. in pediatric patients with Angelman syndrome.
Drugs
FDA and the United Kingdom are expanding their ongoing mutual recognition agreement (MRA) to include animal drug inspections. FDA says this will allow them to rely on each other’s inspection reports and related information, which will avoid duplication of some animal drug inspections and enable regulators to devote more
Drugs
CDER director Patrizia Cavazzoni says agency inspectors are highlighting during inspections the importance of having in place effective risk-based change management and risk-based quality control. Speaking at the Parenteral Drug Association’s annual regulatory conference 9/27, Cavazzoni said this is part of FDA’s push for quality
Drugs
The CDER Office of Generic Drugs (OGD) has revised its scientific priorities as part of its user fee performance goals through 2022. For example, a research priority initiative to develop better methods for evaluating opioid product abuse deterrence that was included in the FY 2020 priorities was removed from the
Drugs
FDA has granted Genmab and Seagen accelerated approval for their BLA for Tivdak (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) for treating adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Approval was based on data from the innovaTV 204 clinical trial that
Drugs
FDA has extended by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency in pediatric patients. The goal date was extended to give the agency more time to review a Pfizer submission of
Drugs
Federal Register notice: FDA has announced a 12/2 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to hear certain updates on NDAs approved under accelerated approval that have not verified clinical benefit. Products being discussed are: (1) Secura Bio’s Farydak (panobinostat) capsules, indicated in combination with bortezomib
Drugs
Emery Pharma is asking FDA to issue a regulation, revise industry guidance, and request a recall and suspend sales of vitamin B6 (pyridoxine) from the U.S. market. A 9/20 petition says mega doses (50-500 mg) of vitamin B6 are widely available over-the-counter and online. When
Drugs
FDA has released an FDA-483 issued following a 7/2-8/12 inspection at Prescription Labs Inc., Houston, TX, a producer of sterile and non-sterile drugs doing business as Greenpark. The 10 inspection observations were: * personnel engaged in aseptic processing were observed with exposed skin; * the firm released
Drugs
IntegraDose Compounding Services is recalling nine lots of antibiotic cefazolin 2g in 20 mL syringes for injection and two lots of cefazolin 3g in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance. The sterility issue was traced to a newly installed biologic
Drugs
FDA has approved Baxter’s premix norepinephrine bitartrate in 5% dextrose injection, indicated for raising blood pressure in adult patients with severe, acute hypotension (low blood pressure). The ready-to-use formulation and is available in 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/
Drugs
FDA says a review of records submitted by Furley Bioextracts SDN BHD, Selangor, Malaysia, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, along with a misbranded unapproved new drug. A 9/13 Warning Letter says specific CGMP
Drugs
FDA says its review of materials submitted by Laboratorio Pharma Internation SRL, Tegucigalpa, Honduras, a manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/15 Warning Letter also says the firm’s Gelazul topical analgesic is a
Drugs
The DC federal court has granted summary judgment to seven compounding pharmacies throughout the U.S. that challenged an FDA 10/2020 Final Standard Memorandum of Understanding (MOU) establishing an agreement between state boards of pharmacy and the agency. The agreement would require those boards that sign it to identify